Status:
RECRUITING
Super Selective Adrenal Artery Embolization for Primary Aldosteronism: a Prospective Cohort Study(SAAE-PA)
Lead Sponsor:
Xinjiang Medical University
Conditions:
Primary Aldosteronism
Super Selective Adrenal Arterial Embolization
Eligibility:
All Genders
18-60 years
Brief Summary
The objective of this study was to evaluate the efficacy and safety of adrenal vein blood extraction for primary aldosteronism classification and adrenal artery embolization in the treatment of primar...
Detailed Description
As one of the causes of refractory secondary hypertension, primary aldosteronism is usually treated with drug therapy and adrenalectomy, but the therapeutic effect of these regimens is limited in some...
Eligibility Criteria
Inclusion
- Age 18-60 years old;
- Primary hyperaldosteronism was diagnosed in strict accordance with the 2016 International Endocrine Society clinical guidelines;
- Refusal of medication due to adverse reactions, refusal of adrenal resection due to surgical risk, or persistent hyperaldosteronism and cortical insufficiency after adrenal resection;
- The patients and their families were introduced in detail to all the current treatment methods for primary aldosteronism, and the adrenal artery embolization was voluntarily accepted;
Exclusion
- A history of severe hypersensitivity to contrast media;
- There are serious complications of liver disease, such as thrombocytopenia, esophageal variceal bleeding, etc;
- Renal insufficiency (serum creatinine \> 176mmol/L or estimated glomerular filtration rate \< min.1.73m2);
- Combined with other secondary hypertension, such as pheochromocytoma, hypercortisolism, renal vascular hypertension (such as renal artery stenosis), renin secretory tumor, renal parenchymatous hypertension, drug-induced hypertension (such as long-term use of glucocorticoids, contraceptives, estrogens, herbs containing glycyrrhizin), pregnancy hypertension and other secondary hypertension;
- Hereditary diseases: such as false aldosteronism (Liddle syndrome), Bartter syndrome, familial hypokalemia and hypomagnesemia (Gitelman syndrome);
- Cerebral apoplexy, myocardial infarction and stent implantation occurred in the past 3 months;
- Serious other basic, such as heart dysfunction (grade IV), acute infection, autoimmune diseases, various malignant tumors and so on;
- Participated in other clinical trials within the past 3 months;
- Individual pregnancy, nursing or planning pregnancy;
Key Trial Info
Start Date :
April 15 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06513676
Start Date
April 15 2024
End Date
August 1 2028
Last Update
July 23 2024
Active Locations (1)
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1
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 630000